EU AI Act Compliance for High-Risk AI Systems
EU AI Act compliance and ISO 42001 program build for B2B SaaS and consulting firms operating AI in the EU market.

Comprehensive EU AI Act Compliance Consulting & End-to-End AI Governance Program Build
Regulation (EU) 2024/1689, the EU AI Act, is the world's first horizontal AI regulation. It entered into force on 1 August 2024 and applies extraterritorially to providers placing AI systems on the EU market, deployers using AI systems in the Union, and any provider or deployer outside the EU whose system outputs are used in the Union. Application is phased and already partially in effect: prohibited practices and AI literacy obligations have applied since 2 February 2025, and GPAI obligations since 2 August 2025. The bulk of high-risk obligations apply from 2 August 2026, with Annex I product-embedded high-risk obligations following on 2 August 2027. Penalties reach €35 million or 7 percent of worldwide annual turnover.
Security Consultants delivers EU AI Act programs that meet both regulator expectations and enterprise customer due diligence. We determine your role (provider, deployer, importer, or distributor), classify your systems against Article 5 prohibitions and Annex III high-risk areas, and build the lifecycle obligations from there: Article 9 risk management, Article 10 data governance with bias diagnostics, Article 11 and Annex IV technical documentation, Article 12 logging, Article 14 human oversight, Article 15 accuracy and adversarial robustness, Article 27 Fundamental Rights Impact Assessment for deployers, Article 43 conformity assessment, and Article 72 post-market monitoring. Most providers run the program on an ISO 42001-aligned AI management system, which carries forward to ISO 27001 evidence on a shared foundation.
Provider vs Deployer Role Determination
We classify your relationship to each AI system against Articles 16 through 27. Substantial modification of a third-party model can trigger provider obligations. Misclassification is the most expensive mistake in an AI Act program and we close it first.
Annex IV Technical Documentation
We build the Annex IV technical file: system description, design specifications, development methodology, training data documentation, validation, deployment, post-market monitoring, and change control. Version-controlled and maintained current after every substantial model update.
Article 15 Adversarial Robustness Testing
Penetration testing of inference pipelines: data poisoning, model evasion, model extraction, membership inference, and prompt injection on generative systems. Evidence the AI Act expects and that documentation alone cannot generate.
ISO 42001 + ISO 27001 on One Evidence Base
An ISO 42001 AI management system is the practical backbone for AI Act compliance. We integrate it with your existing ISMS so the QMS, risk management, and documentation requirements of Article 17 satisfy ISO 42001 Clauses 5 through 10 in one program.
A proven, methodical
approach
Project Kick-Off & Setup
We start with a project kick-off where the manager sets up your engagement in our project management platform. We confirm your role (provider, deployer, importer, distributor, or product manufacturer) for each in-scope AI system, define milestones, name an AI governance lead, and agree the communication plan.
AI System Inventory & Risk Tier Classification
We inventory every AI system you provide or deploy, classify against Article 5 prohibitions, Annex III high-risk areas, Article 50 transparency obligations, and the GPAI regime under Chapter V. Where Article 6(3) derogation applies, we document and justify it.
Article 9 Risk Management & Article 10 Data Governance
We build the lifecycle risk management system: identification, estimation, evaluation, mitigation, and residual risk acceptance under Article 9. Data governance under Article 10 covers provenance, representativeness, bias diagnostics across protected and intersectional categories, and special-category processing under Article 10(5) where strictly necessary.
Annex IV Documentation, Logging & Human Oversight
We deliver the Annex IV technical file, the Article 12 logging architecture with at least six-month retention for deployers and longer where intended purpose requires, Article 13 instructions for use with model card and performance summary, and the Article 14 human oversight design including override and stop functions.
Article 15 Cybersecurity, Conformity Assessment & CE Marking
We test accuracy, robustness, and cybersecurity including adversarial robustness against data poisoning, evasion, extraction, membership inference, and prompt injection. For most Annex III systems we run Annex VI internal control. For biometric ID systems and Annex I product-embedded systems we coordinate Notified Body assessment, EU declaration of conformity under Article 47, and CE marking under Article 48. Registration in the EU database follows.
Post-Market Monitoring, vCISO & Ongoing Assurance
Once the program is live, our vCISO subscription operates Article 72 post-market monitoring, Article 73 serious incident reporting within statutory timelines, annual risk and adversarial robustness re-testing, AI literacy training refresh under Article 4, and Annex IV documentation maintenance through model and data changes. Where independent assurance is required, we run the program to ISO 42001 certification on the same evidence base.